Main responsibilities and accountabilities:
- Be responsible for HGRAC submission and review, including but not limited to the fulfillment of online application form, paper documents collection and paper dossier submission etc according to HGRAC regulation.
- Be responsible for the tracking of online application results. Regular update HGRAC officer for the reason of rejection and work together with CSM/CPL for the application strategy and potential solution.
- Be familiar with the most updated HGRAC related regulation and act as subject matter expert to provide input for continuous improvement of Roche HGRAC application process set up, relevant management process and functional initiatives.
- Provide updated HGRAC information to global and local internal stakeholders and support management on strategic decision-making.
- Setup and maintain database to capture updated HGRAC regulations, lessons leant and FAQ.
- Participate in appropriate professional meetings, symposia, and continuing education programs to maintain knowledge and expertise across the industry.
- Perform other tasks, as assigned or requested by line manager.
University Degree or equivalent, preferably in medical / science-related field. Demonstrated knowledge and understanding of clinical trials and experience in managing projects. Demonstrated knowledge and understanding of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, Good Clinical Practices(ICH-GCP), as well as understanding of the regulatory requirements for starting clinical trials in the relevant country.
Roche is an equal opportunity employer.Research & Development, Research & Development > Clinical Operations